Simulation of Facial Soft Tissue in Orthognathic Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CT scan, VLASTIC test.
- Who it may be relevant to
- Registry conditions: Orthognathic Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Orthognathic surgery consists of rebalancing the position of the jaws, taking into account functional criteria (tooth engagement, tooth/lip ratio, breathing, etc.) and aesthetic criteria. It has become much more accurate in recent years thanks to the advent of osteosynthesis plates and the contribution of three-dimensional imaging. Three-dimensional imaging makes it possible to simulate fairly accurately the surgical procedures and bone displacements required. However, the effect of these bone displacements on the soft tissues (skin, subcutaneous tissue, muscles) does not make it possible, with today's digital tools, to simulate the final aesthetic result and in particular to anticipate the sometimes significant postoperative changes to the face. Many patients are worried about these post-operative morphological changes and would like to have a precise idea of how they will look after surgery. Being able to offer them, before surgery, a visual solution simulating the final aesthetic appearance would be essential in this respect. The aim of the study is to validate the predictions provided by the digital face model on a series of patients scheduled for orthognathic surgery by comparing the simulation of the morphological result of the operation, provided by our algorithm (SPOC), with the actual result assessed on a scan taken 6 months after the operation.
Interventions
- Other CT scan
6 months postop CT scan - Other VLASTIC test
Measurement of the elasticity of the facial integument using the VLASTIC cutometer (Volume-based Light Aspiration device for in vivo Soft Tissue Characterization)
Primary outcome measures
- Validation of the predictions provided by the digital face model (SPOC). [Time frame: 6 months after orthganthic surgery]
Eligibility criteria
Inclusion criteria
- Patient over 18 ;
- Patients who have been informed of the study and who have freely given their informed consent to participate in the study;
- Patient undergoing isolated mandibular or maxillary orthognathic surgery, or maxillo-mandibular surgery with or without genioplasty for any indication (occlusal disorder, sleep apnoea syndrome, functional joint disorder, etc.);
- Patient covered by a French social security scheme
Exclusion criteria
- Patient with maxillary disjunction ;
- Patients with facial malformations;
- Pregnant or breast-feeding patient;
- Patient under guardianship;
- Patients who do not understand French;
- Patients under court protection
- No pre- or postoperative CT scan or CT scan that cannot be used
- Surgery, trauma, progressive infection or cosmetic injection on the face after orthognathic surgery and before the postoperative scan
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- CH Annecy Genevois — Annecy
Identifiers
NCT: NCT06822127 · 24-02 · 2024-A02357-40